Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Applicant’s arguments, filed 9/26/2025, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Priority
This application is a domestic application filed 04/26/2021, and claims benefit as a CON of 15/862,171, filed 01/04/2018, now PAT 10987366, and 15/862,171 is a CON of 13/822,223, filed 04/22/2013, now PAT 9877976, and 13/822,223 is a 371 of PCT/US2011/051946, filed 09/16/2011, and PCT/US2011/051946 claims benefit of PRO 61/383,592 09/16/2010.
However, as stated in the previous office action, the above parent applications upon which priority is claimed fail to provide adequate support under 35 U.S.C. 112 for instant claim 33 of this application since all parent applications are not seen to disclose the following in the instant independent claim: A method of performing a CT scan on a subject, the method comprising administering to the subject an effective dose of a phosphorothioate compound or derivative thereof to the subject within 5 hours prior to exposure to the CT scan radiation. Thus, the filing date of the instant claims is deemed to be the filing date of PCT/US2011/051946, 9/6/2011.
Applicant’s arguments have been fully considered but are not found persuasive. Although the examiner agrees that support for the present claims is found in PCT/US2011/051946, 9/6/2011, they cannot locate where support is found in the earlier priority document(s).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 33-34, 36-37, 39, 41-44, 46-50, and 52-55 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Koukourakis (American Journal of Clinical Oncology, 2009, Vol. 32, No. 3, pages 258-261). Koukourakis is directed to computed tomography assessment of subjects with cancer that are treated with amifostine (a phosphorothioate, an antioxidant). Specifically, it is disclosed that radiotherapy was delivered based on CT imaging to subjects (see entire document especially, abstract; page 258, right column, first complete paragraph; page 258, fourth complete paragraph). The subjects were administered 500-1000 mg of amifostine 20 minutes before each radiotherapy session, which reads on “within 5 hours prior to exposure to the CT scan radiation” (Materials and Methods). After therapy, a CT scan was performed once every 2 months for the first 6 months and once every 3 months thereafter (page 259, left column, first complete paragraph; page 259, right column second complete paragraph). In Figure 4, lung tissue is disclosed based on a CT scan before and after radiotherapy wherein a daily dose of amifostine is given to the subject (page 260, Figure 4). For the reasons included herein, both Applicant and Koukourakis et al disclose performing a CT scan. Phosphorothioate compounds are compounds that act as antioxidants, which fairy reads on “administering to the subject an antioxidant.”
Applicant argues that Koukourakis does not teach “within 5 hours prior to exposure to the CT scan radiation” as the administration of 500-1000 mg of amifostine is 20 minutes before each radiotherapy session, which is different from a CT Scan.
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s Exhibit A, the examiner notes that for rebuttal evidence to be considered in the record, it should be included in an IDS. The examiner further notes that the exhibit is a disclosure presenting general guidance to patients undergoing radiotherapy at MD Anderson Cancer Center as of 10/29/2021. It is not a guide to methods of treatment, nor does it indicate the state of the art at the timeframe that is presently under consideration, that is, before the effective filing date of the application, which is 9/6/2011, a little over a decade before the exhibit appears to have been published.
Regarding the section cited by applicant in Koukourakis, the artisan would understand that the CT scan is performed as part of the radiotherapy procedure, the CT scan conducted prior to administration of radiation in the radiotherapy procedure, so as to allow for the most up-to-date targeting of the radiation. Further, the artisan would immediately envisage performing the CT scan just prior to administration of radiation to provide the most current imaging of the patient, creating a precise, customized treatment plan by capturing a 3D image of the patient's anatomy in the exact position they will be in during treatment. This ensures the radiation beams accurately target the tumor while minimizing damage to surrounding healthy tissues, a critical step for treatment success and patient safety.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 33-34, 37, 39, 41-44, 46-50, and 52-55 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Koukourakis (American Journal of Clinical Oncology, 2009) in view of Tao (The effect of prophylactic oral vitamin C use on DNA double-strand breaks after abdominal contrast-enhanced CT: A preliminary study, European Journal of Radiology 117 (2019) 69–74). The relevant portions of Koukourakis are given above.
Koukourakis fails to teach administration of one of the oxidants required by claim 53. Koukourakis further fails to teeach wherein the CT radiation dosage is 0.2-20 mSv.
Tao teaches that taking antioxidants such as Vitamin C (ascorbic acid) 20 minutes before a CT scan reduces the effects of radiation exposure on the body, including DNA damage (Abstract; Results; Discussion)
It would have been obvious to one of ordinary skill in the art at the time the invention was made to administer Vitamin C (ascorbic acid) prior to the CT scan. The motivation for this would have been to reduce the effects of radiation exposure, such as DNA damage, on the body. It would have been further obvious to optimize the CT radiation dosage to reduce the effects of radiation exposure on the body, and in this way, the artisan would find 0.2-20 mSv through routine experimentation.
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s argument that Tao does not cure the deficiencies of Koukourakis, the examiner’s response is that Tao was relied on for its teaching that taking antioxidants such as Vitamin C (ascorbic acid) 20 minutes before a CT scan reduces the effects of radiation exposure on the body, including DNA damage (Abstract; Results; Discussion). In view of Tao, it would have been obvious to administer Vitamin C (ascorbic acid) prior to the CT scan. The motivation for this would have been to reduce the effects of radiation exposure, such as DNA damage, on the body.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
November 28, 2025
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